Remoxy is being developed as an abuse-resistant version of long-acting oxycodone. It is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimise risks of drug diversion, abuse or accidental patient misuse.
Remoxy has a sticky, high-viscosity mass that resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol for hours at a time releases just a fraction of oxycodone compared to Oxycontin at time points when abusers presumably expect to get high.
The companies believe these and other physical properties of Remoxy may deter recreational abuse or accidental patient misuse of long acting oxycodone.
Under the terms of the agreement, King will make an upfront payment of $150 million in cash to Pain Therapeutics.
Pain Therapeutics could also receive additional milestone payments of up to $150 million in cash based on the successful clinical and regulatory development of Remoxy and other abuse-resistant opioid products.
This amount includes a $15 million cash payment upon acceptance of a regulatory filing for Remoxy and an additional $15 million upon its approval.
King is responsible for all R&D expenses related to this alliance, which could total $100 million.
"This alliance is the culmination of an extensive screening process for late-stage development opportunities in the pain market. We have focused our licensing efforts toward the unmet medical needs in today's evolving pain market," said Brian Markison, president and chief executive officer of King Pharmaceuticals.
Additonal terms of the agreement will see King record net sales of all products and pay Pain Therapeutics a 20 per cent royalty, except as to the first $1 billion in cumulative net sales, which royalty is set at 15 per cent.
King is also responsible for the payment of third-party royalty obligations of Pain Therapeutics related to this alliance.
According to Frost & Sullivan, over 50 million people are affected by severe chronic pain in the United States. Due to the aging population, better physician training in pain management and other factors, opioid sales are rising and are expected to exceed $7 billion in 2009
IMS Health data have placed Oxycodone as the leading opioid used in the treatment of moderate-to-severe pain, with US sales of nearly $2 billion for the 12-months ending August 2005.
Oxycodone is also the active drug ingredient in Remoxy and in the branded product Oxycontin. Drug abusers can easily extract oxycodone from Oxycontin tablets in order to induce a quick and powerful euphoric high.
Pain Therapeutics is currently designing a pivotal Phase III study with Remoxy in patients with severe chronic pain. This randomised, placebo-controlled Phase III clinical trial will enroll 400 patients with moderate-to-severe chronic pain in multiple US clinical sites.
This trial is expected to begin in January 2006 and to be completed by December 2006. If this Phase III clinical trial is successful, a New Drug Application for Remoxy could be filed with the FDA in 2007.